WO2014041440A1

WO2014041440A1 - Honey-based dressing for the treatment of wounds and burns

Info

Publication number: WO2014041440A1
Application number: PCT/IB2013/050962
Authority: WO
Inventors: Carlos A. Alvarado
Original assignee: Individual
Current assignee: Individual
Priority date: 2012-07-16
Filing date: 2013-02-05
Publication date: 2014-03-20
Anticipated expiration: 2015-01-16
Also published as: US20160346335A1

Description

HONEY-BASED DRESSING FOR THE TREATMENT OF WOUNDS AND BURNS

DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

DEFINITIONS

In the discussions herein, a number of terms are used. In order to provide a clear and consistent understanding of the specification and claims, the following definitions are provided.

Acute - sharp, severe, having rapid onset, severe symptoms and a short course, not chronic

Angiogenesis - This occurs during the proliferative phase of healing when new blood vessels infiltrate the wound and endothelial budding forms capillaries.

Adhering dressing - the quality of clinging or being closely attached

Antimicrobial agent - preventing the development or pathogenic action of microbes, helps decrease an infection and allows healing of a wound

Antiseptic - A substance that inhibits the growth and development of microorganisms without necessarily killing them. Antiseptics are usually applied to body surfaces.

Bacterial - unicellular microorganisms, lacking chlorophyll, many different kinds of bacteria, germs, creating an infection

Chronic - long, drawn out, applied to a disease that is not acute.

Chronic wound - covered with necrotic (dead) material and surrounded by cellulites, also is described as an infected wound.

Connective tissue - Refers to tissue that protects and supports the body and its organs, and tissues that bind organs together.

Debridement - the process of removing dead/unhealthy and/or contaminated tissues, foreign bodies, and other debris on the wound, using mechanical, enzymatic or sharp techniques.

Disinfectant - A chemical or mixture of chemicals used to kill microorganisms, usually applied to inanimate surfaces or objects.

Disinfection - A physical or chemical means of killing microorganisms, but not necessarily spores.

Dressing - Any of various materials utilized for covering and protecting a wound. Edema - a condition in which the body tissues contain an excessive amount of tissue fluid. It may be local or general swelling

Enzymatic activity - an organic catalyst produced by living cells (as in digestive juices), but capable of acting independently of the cells producing them. They are capable of inducing chemical changes in other substances without themselves being changed in the process.

Epidermis - the outer layer of skin

Epithelialization-The process of the formation of new epithelial tissue -the upper layer of the skin-.

Eschar - a slough, especially one following a cauterization or burn - any agent used to destroy dead tissue and to cause sloughing which produces an eschar (a blackened area) in the treatment of skin disease

Excision - Is a surgical procedure requiring incision through the deep dermis (including subcutaneous and deeper tissues) of open wounds, burn eschar, or burn scars.

Exudates - the tan/grayish material that often forms over an open wound. It consists of proteinaceous material from the wound itself.

Granulation tissue - Newly formed vascular tissue (fragile capillaries) normally produced in the healing of wounds of soft tissue and ultimately forming the scar; it consists of small, translucent, pink to red, nodular masses of granulations that fill in an open wound bed during the proliferative phase of healing.

Infection - The host response to bacterial, viral or similar invasion.

Inflammation - A non-specific host response to invasion of foreign material.

Lesion - any visible, local abnormality of the tissues of the body, as a wound, sore, rash, or a boil. A lesion may be described as benign, cancerous, gross, occult, or primary

Necrosis - localized tissue death that occurs in groups of cells in response to disease or injury, as an example - blood clots may block the flow of blood causing tissue ischemia below the blood clot, or ischemia combined with bacterial action can cause gangrene to set in

Purulent - producing or containing pus Ripe honey - It is meant honey naturally produced by bees to have water content, in a range known to those skilled in the art, which typically varies from about 14% to about 18% water by weight.

Sterilization - A process that kills and/or removes all classes of microorganisms and spores.

Stroma -The supportive framework of an organ usually composed of connective tissue. Superficial - confined to the surface

Transparent dressing - a dressing that you can see through and visualize the ulcer, but can be occlusive (taped on all four sides)

Tissue regeneration - Healing in which lost tissue is replaced by proliferation of cells which reconstruct the normal architecture.

Tissue repair - Healing in which lost tissue is replaced by a fibrous scar, which is produced from granulation tissue.

Treatment or treating - refers to any means of control of a condition or disorder, including prevention or prophylaxis, cure and relief, or relief of development of the condition or disorder.

Ulcer - a circumscribed, craterlike lesion of the skin or mucous membrane resulting from necrosis that accompanies some inflammatory, infectious, or malignant processes. An ulcer may be shallow, involving only the epidermis, or a deep crater going down to the bone

Wound dressing - is a material applied to a wound or a diseased part of the body, with or without medication, to protect and assist healing.

The invention is directed to a practical active dressing (PAD) honey-based composition, methods of producing the same, and therapeutic applications arising from their utilization.

In one embodiment, the term "practical active dressing", "(PAD)", "dressing" or "wound dressing" refers to three-dimensional structure capable of covering-protecting a wound, performing autolytic debridement (moisture donation) and induction of angiogenesis. In another embodiment, any reference to "including humans" placed after references to "warm blooded vertebrates" is intended to clarify that whilst humans are contemplated as recipients of the PAD composition.

In another embodiment the ripe honey of bee for use in the (PAD) composition in accordance with the invention are typically prepared whit a preferred viscosity, a preferred pH, a preferred gelling agents, a preferred chemical compounds (for example antimicrobial) and preferred plant extracts.

In accordance whit one embodiment, the preparation of a PAD is carried out by the addition of preferred components (group of methyl-phenol and acetic acid constituents), and plant extract (Trigonella foenum-graecum), to the ripe honey, that synergistically enhancing the antimicrobial activity, performing autolytic debridement and the induction of angiogenesis that is beneficial to healing of wounds.

The combination of these components results in the preparation of a PAD composition that is non-immunogenic, and, thus, does not induce an adverse host immune response when it is used to wound covering, for performing autolytic debridement (moisture donation) and induction of angiogenesis into a host.

In another embodiment, this invention provides a process for preparing a practical active dressing (PAD) honey-based composition, and in general, the method for preparing the dressing comprises the steps of obtain ripe honey of bee from proper suppliers that ensure good manufacturing practices. In a First Process the operator proceed to Reagent No. 1 preparation by mix Trigonella foenum-graecum seed, demineralized water and vinegar and let stand for three days. Then, in a Second Process the operator proceeds to mix the supernatant of reagent No. 1 with ripe honey, Agar Agar and the methil-phenil composition. After that, in a Third Process the operator proceeds to boil this composition until the time of starting the ebullition process. Next, in a Fourth Process proceed to distribution this mixed composition in and individual box and leave to dry in an environment free of contaminants. Each box should be packaged individually into a vacuum bag (multi-layer synthetic bag) and the bag then is sealed. Afterward, in a Fifth process proceed to Eto Sterilization, which is carried in special chamber, for 24 hours and then air exposed for other 24 hours. In another embodiment, the use of the practical active dressing (PAD) honey-based composition, in cases where native tissue is damaged, in one embodiment, by trauma, or in another embodiment, by burns, or in a further embodiment by vascular skin complications (chronic ulcers).

In accordance with one embodiment, such practical active dressing compositions enables a surgeon to utilize this composition in a diverse range of surgical applications such as burns, wounds, vascular skin complications (chronic ulcers) or extensive injuries presented in theaters of war.

Thus, another embodiment of this invention is a method of implanting into the vertebrate the PAD composition, prepared as described above comprising the combination of active ingredients of ripe honey, gelling agents (Agar Agar), plant extracts (Trigonella foenum-graecum) and chemical compounds (group of Methyl-phenol and acetic acid) in an amount effective to reduce the pH for the regulation of bacterial growth, to performing Autolytic debridement and induce angiogenesis at the site of administration of the wound dressing.

In another embodiment, it is thus the object of the present invention to provide an agent for topical application which has a broad application spectrum and thus may be employed for a plurality of uses, which are as close to natural as possible, and thus is well tolerable without any negative side effects.

In another embodiment, the PAD composition produced and used in accordance with this invention, upon implantation, can serve for the growth of new endogenous connective tissues in the warm-blooded vertebrate including humans.

Connective tissues for the purposes of the present invention include the dermal layer of skin. In accordance with this embodiment, the PAD composition is used beneficially for wound debridement and induction of angiogenesis from the surrounding connective tissue at a desired site in a warm-blooded vertebrate including humans.

In another embodiment, this invention provides a method of implanting a dressing of this invention in a subject for immediate wound cover, as show in example # 2 in this discovery.

In another embodiment, the practical active dressing is implanted in direct contact with the wound bed. In one embodiment, the dressing becomes sufficiently adhered to the wound bed, thoroughly integrated at all levels, and will performing wound debridement, induction of angiogenesis and preparation of the wound area for skin autograft, where such is considered additionally required.

In another embodiment, is contemplated the use of the combination of active ingredients of ripe honey, gelling agents (Agar Agar), plant extracts (Trigonella foenum- graecum) and chemical compounds (group of Methyl-phenol and acetic acid) for the manufacture of other treatment methods or medical applications or products which have not been discussed in the present application, e.g., topical formulations (creams, ointments, gels), transdermal systems, microspheres for drug delivery system, or used for the purpose of improving, developing or enhancing other biotechnological/biological products.

As can be seen from the forgoing description, the concepts of the present disclosure provide numerous advantages

The following examples are presented in order to more fully illustrate the preferred embodiments of the invention. They should in no way be construed, however, as limiting the broad scope of the invention.

Claims

1 . A practical active dressing (PAD) honey-based composition capable of covering- protecting a wound, performing autolytic debridement (moisture donation) and induces angiogenesis, when is positioned in warm-blooded vertebrate including human subjects. It comprises the combination of active ingredients of ripe honey, gelling agents (Agar Agar), plant extracts (Trigonella foenum- graecum) and chemical compounds (group of Methyl-phenol and acetic acid).

2. The method for preparing a honey-based composition to render it useful for the purposes described herein.

3. The honey-based composition will have a preferred viscosity, a preferred pH, a preferred gelling agent, a preferred chemical compounds (for example antimicrobial) and preferred plant extracts.

4. The honey-based composition of claim 3, in which the preferred gelling agent is Agar Agar, in which the preferred chemical agent by means of pH reduction is Policresulen (Condensation product of metacresolsulfonic acid & methanal), in which the preferred plant extract is from Trigonella foenum-graecum seeds.

5. The honey-based composition of claim 1 , wherein the practical active dressing (PAD) is positioned by surgical means into the warm-blooded vertebrate including human subjects, according of the second example in the present invention.

6. The method of claim 5, wherein said method is used in the treatment of skin loss or damage caused by any type of injury or disease or surgical intervention conducted according to the methods of this invention.

7. A method for inducing the formation of endogenous tissue at a site in need of endogenous tissue growth in a warm blooded vertebrate including human subjects, said method consists of contacting said site with a practical active dressing (PAD) comprising the combination of active ingredients of ripe honey, gelling agents (Agar Agar), plant extracts (Trigonella foenum- graecum) and chemical compounds (group of Methyl-phenol and acetic acid).

8. The use of honey-based composition of claim 1 in the manufacture of other treatment methods or medical applications which have not been discussed in the present application, e.g., topical formulations (creams, ointments, gels), transdermal systems, microspheres for drug delivery system, or used for the purpose of improving, developing or enhancing other biotechnological/biological products.